A tentative agenda for "Topical Drug Development -- Evolution of Science and Regulatory Policy" is available below for the convenience of conference attendees.

This two-day workshop is scheduled for July 29-30, 2019. It will be held at the University of Maryland School of Pharmacy, located at 20 N. Pine Street in Baltimore, Md.

Download a printer-friendly agenda here.

Monday, July 29, 2019

TimeActivity
8:30 – 9 a.m. Welcome and Opening Remarks
Audra Stinchcomb, PhD (Professor, UMSOP)
E. Dennis Bashaw, PharmD (FDA)
Morning Session Challenges in Topical Drug Development
Session Chair: E. Dennis Bashaw, PharmD (FDA)
9 – 10 a.m. An Overview of Absorption and Skin Factors
Sheila Fallon Friedlander, MD
Professor of Dermatology and Pediatrics
University of California, San Diego School of Medicine

A History of Dermal Absorption Assessment at the FDA: Quo Vadis?
E. Dennis Bashaw, PharmD
Senior Science Advisor to Immediate Office
Office of Clinical Pharmacology
U.S. Food and Drug Administration
10 – 10:15 a.m. Coffee Break
10:15 – 11:15 a.m. Clinical Experience in the NDA Setting with the Maximal Usage Study Paradigm
Chinmay Shukla, PhD
Dermatology Team Leader
Office of Clinical Pharmacology
U.S. Food and Drug Administration

Current Regulatory Perspectives for Dermal Absorption Under the OTC Monograph
Luke Oh, PhD
Special Monograph Team
Office of Clinical Pharmacology
U.S. Food and Drug Administration
11:15 – 11:45 a.m. Panel Discussion
Moderator: Sojeong Yi, PhD
11:45 – 12:55 p.m. Lunch and Networking
Includes Selected Poster Session
Afternoon Session Considerations in Topical Drug Development in the OTC and NDA Setting
Session Chair: Chinmay Shukla (FDA)
1 – 2 p.m. The FDA Sunscreen Study: Lessons Learned and to be Learned
Murali Matta, PhD
Bioanalytical Lead, Division of Applied Regulatory Science
Office of Clinical Pharmacology
U.S. Food and Drug Administration

Dermal Absorption in the Setting of OTC Rulemaking
Theresa M. Michele, MD
Director, Division of Nonprescription Drug Products
U.S. Food and Drug Administration

Jane J. Sohn, PhD
Pharmacology Team Leader
Division of Nonprescription Drug Products
U.S. Food and Drug Administration
2 – 2:15 p.m. Coffee Break
2:15 – 3:15 p.m. MUsT: Must-Have Study in Topical Drug Development
Nathalie Wagner, MSc
Senior Clinical Pharmacokinetics Manager
Global Clinical Development
Nestle’ Skin Health

Analysis and Interpretation of Systemic Exposures from Topical Agents: Learnings from Crisaborole Ointment
Vivek Purohit, PhD
Director, Clinical Pharmacology
Global Product Development
Pfizer, Inc.
3:15 – 3:45 p.m. Panel Discussion
Moderator: Da Zhang, PhD
3:45 – 4 p.m. Break
4 – 5 p.m. Q&A with All Speakers
5 p.m. Daily Close
Audra Stinchcomb, PhD
Professor of Pharmaceutical Sciences
University of Maryland School of Pharmacy

Tuesday, July 30, 2019

TimeActivity
Morning Session In Vitro Methods and Application in Topical Drug Development
Session Chair: Audra Stinchcomb, PhD
9:15 – 10:45 a.m. Heat Effects on Multi-Application Sunscreen Use: IVPT to Healthy Volunteers
Audra Stinchcomb, PhD
Professor of Pharmaceutical Sciences
University of Maryland School of Pharmacy

A Generic Perspective on the Use of In Vitro Assessment Methods
Sam Raney, PhD
Lead for Topical and Transdermal Drug Products
Office of Generic Drugs
U.S. Food and Drug Administration

In Vitro Permeation Test: Practical Considerations in Its Method Development and Implementation
Leandro L. Santos, MSc
Associate Director, Clinical Sciences
Incyte Corporation
10:45 – 11 a.m. Coffee Break
11 – 12:30 p.m. The Use of IVPT as a Tool in Developing Topical Drug Products
Vijendra Nalamothu, PhD
Chief Executive Officer
Tergus Pharma

Integration of IVPT and MUsT into the Safety Assessment of OTC Products
Sojeong Yi, PhD
Special Monograph Team
Office of Clinical Pharmacology
U.S. Food and Drug Administration

Utility of Quantitative Pharmacology and Pharmacometrics in Investigating Active Sunscreen Ingredients Absorption
Da Zhang, PhD
Special Monograph Team
Office of Clinical Pharmacology
U.S. Food and Drug Administration
12:30 – 1 p.m. Panel Discussion
Moderator: Sojeong Yi, PhD
1 p.m. Closing Remarks and Next Steps
E. Dennis Bashaw, PharmD
Senior Science Advisor to Immediate Office
Office of Clinical Pharmacology
U.S. Food and Drug Administration